Multiparametric SCores for Prediction of Myocardial fIbrosis in Patients With MITral vAlve pRolapse (SCIMITAR)

Multiparametric SCores for Prediction of Myocardial fIbrosis in Patients With MITral vAlve pRolapse: the SCIMITAR Trial

This is a multicenter, observational prospective and retrospective study which aims are: 1) to compute a scoring model potentially predictive for the diagnosis of fibrosis by CMR in patients with MVP; 2) to identify specific features that may predispose to ≥ mild VAs or SCD in patients with MVP.

Study Overview

• Status: Recruiting
• Conditions: Mitral Valve Prolapse

Detailed Description

Patients with mitral valve prolapse and non-significant mitral regurgitation generally have a good prognosis. A minority of patients with MVP suffers from ventricular arrhythmias. Different demographic, clinical, and electrocardiographic characteristics, as well as morphological and structural features of the MV were described as potential risk factors for ventricular arrhythmias, among which fibrosis of the left ventricular inferolateral wall and posterior papillary muscle as detected by cardiac magnetic resonance.

As cardiac magnetic resonance has some limitations, it is unknown if and which patients with mitral valve prolapse should undergo cardiac magnetic resonance in routine clinical practice, to search for late gadolinium enhancement as a surrogate for myocardial fibrosis.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Gianluca Pontone, MD; Phone Number: +39 0258002574; Email: gianluca.pontone@cardiologicomonzino.it

Study Locations

• Italy
  • Milan, Italy, 20131
    • Recruiting
    • Centro Cardiologico Monzino
    • Contact: Chiara Centenaro; Phone Number: +39 0258002031; Email: chiara.centenaro@cardiologicomonzino.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of mitral valve prolapse by transthoracic echocardiography, independent of mitral regurgitation grade, either affected by Barlow's disease, fibroelastic deficiency, forme frustae of mitral valve prolapse.

Description

Inclusion Criteria:

• age ≥ 18 years
• Echocardiographic diagnosis of mitral valve prolaspe, defined as a systolic displacement of one or both mitral leaflets ≥ 2 mm above the plane of the mitral valve annulus in long-axis views

Exclusion Criteria:

• age< 18 years
• coexistence of other cardiomyopathies or other ≥ moderate valve diseases
• scarce acoustic transthoracic echocardiographic window
• usual contraindications for cardiac magnetic resonance

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Prospective Cohort; Prospectively enrolled patients will undergo a complete assessment, as clinically indicated, including clinical evaluation, TTE, rest ECG, 24h ECG-monitoring, and CMR. CMR will be performed no more than 6 months apart from other examinations (TTE, rest ECG, 24h ECG-monitoring).
Retrospective Cohort; Patients will be enrolled retrospectively, in case they have already performed all examinations between 2016 and 2023

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prediction of fibrosis by CMR	Clinical, echocardiographic, electrocardiographic, and 24h-ECG monitoring variables will be collected in order to identify potential predictors of fibrosis as detected by cardiac magnetic resonance (CMR). Specifically, the following parameters will be collected.; Clinical data:; Transthoracic echocardiography parameters:; Rest ECG parameters:; 24h electrocardiographic monitoring parameters:; Ventricular arrhythmias (VAs) will be classified as suggested in the recently published EHRA consensus statement; CMR parameters, applying the protocol of the Society of Cardiovascular Magnetic Resonance	June 2026

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prediction of ≥ mild Ventricular Arrhythmias and/or Sudden cardiac death in mitral valve	Clinical, echocardiographic, electrocardiographic, and CMR variables will be collected in order to identify potential predictors of ≥mild VAs, as defined by the recently published EHRA consensus document. An accurate description of these variables and the Units of Measure are the same as those reported in the section "Primary Outcome Measures".	June 2026

Collaborators and Investigators

• Sponsor: Centro Cardiologico Monzino
• Collaborators: Humanitas Hospital, Italy; Treviso Regional Hospital; IRCCS Ospedale San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2023
• Primary Completion (Estimated): June 19, 2025
• Study Completion (Estimated): June 19, 2025

Study Registration Dates

• First Submitted: March 14, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Valve Diseases; Heart Valve Prolapse; Prolapse; Mitral Valve Prolapse
• Other Study ID Numbers: CCM1959

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No